BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PRIMOTEC LLC

    Reg #: 3004491043 · FEI: 3004491043 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    8

    Registration Details

    Registration Name
    PRIMOTEC LLC
    Registration Number
    3004491043
    FEI Number
    3004491043
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    215 Westport Ave
    City
    Norwalk
    State
    CT
    ZIP
    06851
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141421

    Owner / Operator

    Firm Name
    Primotec LLC
    Operator Number
    10041713
    Address
    360 Westport Ave.
    City
    Norwalk
    State
    CT
    Postal Code
    06851
    Country
    US
    Correspondent
    Christopher Urist

    Products

    Device Name Product Code
    Crown And Bridge, Temporary, Resin EBG
    Maintainer, Space Preformed, Orthodontic DYT
    Denture, Plastic, Teeth ELM
    Alloy, Gold-Based Noble Metal EJT
    Powder, Porcelain EIH
    Alloy, Metal, Base EJH
    Mouthguard, Prescription MQC
    Material, Tooth Shade, Resin EBF

    Proprietary Names

    CLEAR FLEX primoflex CLEAR AGC Primotec ZRT PREMIOtitan Primosplint PrimoPink PREMIOtemp REF-LINE

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198